FDA Inspection 860977 — Chartwell Pharmaceuticals Carmel LLC
The FDA completed an inspection of Chartwell Pharmaceuticals Carmel LLC on December 23, 2013 in Carmel, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 23, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carmel, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |